Actively Recruiting
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-05-12
130
Participants Needed
5
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy. This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48. This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.
CONDITIONS
Official Title
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with rheumatoid arthritis according to 1987 American College of Rheumatology or 2010 American College of Rheumatology/European League Against Rheumatism criteria
- Moderate or high disease activity
- Synovial biopsy showing a myeloid-stromal pathotype
- Good compliance and willingness to participate, with signed informed consent
You will not qualify if you...
- Received conventional synthetic disease modifying anti-rheumatic drugs treatment within 12 weeks before randomization
- Received biologic agents treatment within 6 months before randomization
- Received Janus kinase inhibitor treatment before randomization
- Serious diseases under control (e.g., diabetes) or serious respiratory, gastrointestinal, or blood system diseases
- Moderate to severe congestive heart failure (NYHA grade III or IV) or recent serious cardiovascular events
- Blood counts below specified thresholds during screening
- Active chronic liver disease or abnormal liver function exceeding twice normal limits
- Estimated glomerular filtration rate below 30 ml/min during screening
- History of symptomatic or recurrent herpes virus infections
- Active or latent tuberculosis without at least 4 weeks of prophylactic treatment
- Positive tests for hepatitis C, syphilis, HIV, or hepatitis B surface antigen without prophylactic antiviral treatment
- History or signs of lymphoproliferative diseases
- Active malignant tumors or history of malignant tumors within 5 years, excluding certain skin and cervical carcinomas considered cured
- History or high risk of thromboembolism
- Major surgery within 4 weeks before randomization or planned after enrollment
- History of chronic pain that may affect study evaluation
- Previous organ transplantation
- History of mental illness, alcoholism, or substance abuse
- Pregnant or lactating women, or men or women planning to conceive soon
- Other factors that may affect study progress or results as judged by researchers
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Foshan Hopsital of Traditional Chinese Medicine
Foshan, Guangdong, China, 528000
Actively Recruiting
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
3
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 511400
Actively Recruiting
4
Pu Ning Shi Ren Ming Yi Yuan
Jieyang, Guangdong, China, 515300
Actively Recruiting
5
Shenshan Medical Central, Memorial Hospital of Sun Yat-sen University
Shantou, Guangdong, China, 516621
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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